Suture storage devices, systems, and methods

ABSTRACT

Devices, systems, and methods are provided for managing suture filaments when performing soft tissue repair. One exemplary embodiment of a surgical suture management device is in the form of a suture loop management card. The card can generally be configured to hold open a collapsible loop of suture until a force applied to the loop is greater than a threshold tension. The card can include a number of different features that help to keep the loop open until the threshold tension is achieved, including features designed to prevent the filament from being mistakenly offloaded. The card can be configured to be removably inserted into a handle of an inserter tool for use as a surgical tissue repair system. Other devices, systems, and methods for performing soft tissue repair are also provided.

CROSS REFERENCE TO RELATED APPLICATION

The present application claims priority to and is a divisional of U.S.application Ser. No. 13/800,566, filed Mar. 13, 2013, and entitled“SUTURE STORAGE DEVICES, SYSTEMS, AND METHODS,” which is herebyincorporated by reference in its entirety.

FIELD

The present disclosure relates to devices, systems, and methods forsecuring soft tissue to bone, and more particularly relates to managingsuture filament used to secure the tissue to bone.

BACKGROUND

A common injury, especially among athletes and people of advancing age,is the complete or partial detachment of tendons, ligaments, or othersoft tissues from bone. Tissue detachment may occur during a fall, byoverexertion, or for a variety of other reasons. Surgical interventionis often needed, particularly when tissue is completely detached fromits associated bone. Currently available devices for tissue attachmentinclude screws, staples, suture anchors, and tacks, at least some ofwhich are used in conjunction with suture to perform repair procedures.

Devices that use suture to help secure tissue to bone often presentdifficulties in suture management during the repair procedure. Even whenjust a single suture filament is used as part of a repair system, thatfilament typically has multiple limbs that must be accounted for duringthe repair. For example, in some embodiments a filament includes twolimbs that extend from one side of a suture anchor and two other limbsthat extend from the other side of the suture anchor. When a surgeon isutilizing an inserter tool to implant the anchor, the four terminal endscan be in the surgeon's way. However, once the anchor is implanted,surgeons generally want to be able to easily access the terminal endsthat were previously in their way so they can use the suture to securethe tissue to bone.

Features currently used to assist in suture management by placingterminal ends out of the way during anchor implantation often requirethe surgeon to perform multiple steps to subsequently access theterminal ends after the anchor is implanted. For example, an insertertool may have suture terminal ends extending from one side of the anchorstored in a first location and suture terminal ends extending from theother side of the anchor stored in a second location a distance apartfrom the first location. In order to access all of the terminal ends foruse in securing tissue to bone, the surgeon must perform one action toaccess the terminal ends stored at the first location and another actionto access the terminal ends stored at the second location. These actionsare further complicated by the need to hold the accessed set of terminalends while performing the second action to access the second set ofterminal ends.

Additionally, devices currently used to manage sutures can be difficultto use, which can lead to misuse by the operator. Misuse of a suturemanagement device can defeat its intended purpose. For example, if asuture management device is configured to hold open a loop of aparticular portion of suture until terminal ends are passed through, butthe surgeon mistakenly collapses the loop before passing the terminalends through the loop, such failure can result in a suture that is nolonger useful to the surgeon. The surgeon may then have to remove theanchor and suture and begin the implantation portion of the procedureagain.

Accordingly, it is desirable to provide devices, systems, and methodsthat make it easy for surgeons to manage suture when implanting anchors,but also easy to access and use the suture after the anchor isimplanted. It is also desirable to reduce the number of steps to beperformed by the surgeon to implant the anchor, access the suture afterthe anchor is implanted, and subsequently use the suture to attachtissue to bone. Further, it is desirable to incorporate mechanisms intodevices and systems used in soft tissue repair that reduce thelikelihood of operator errors.

SUMMARY

Devices, systems, and methods are generally provided for managingsurgical suture filaments during soft tissue repair. In one exemplaryembodiment, a surgical suture management device includes a suture loopmanagement card configured to hold open a collapsible loop of suture.The suture management card can include first and second ends that definea length of the card, first and second sidewalls extending between thefirst and second ends that define a width of the card, and first andsecond surfaces that define a thickness of the card. In someembodiments, the suture management card can be substantially rectangularin shape. A plurality of adjacent slots can be formed in the card anddisposed between the first and second ends. Each slot can extend fromthe first sidewall and toward the second sidewall, and can be configuredto receive a portion of one or more limbs of the suture that also formthe collapsible loop.

The card can have a number of useful features associated therewith. Forexample, an opening can be formed in the second end of the body and canbe configured to receive a distal portion of one or more limbs of thesuture. The first end of the card can include first and second prongsthat are configured to hold open the collapsible loop of suture until aforce applied to the loop is greater than a threshold tension. In someembodiments, the first end can include an opposed pair of seatinggrooves formed in the first surface of the card. Each seating groove canextend diagonally from the first end and toward the second end, with theseating grooves meeting at a vertex substantially centered between thefirst and second sidewalls and in communication with a longitudinalseating groove formed in the first surface of the card. The seatinggrooves can be configured to receive a length of the collapsible looptherein and the longitudinal seating groove can be configured to receivea sliding knot of the collapsible loop.

The plurality of slots can include a first slot and a second slot, withthe first and second slots being substantially parallel to one anotherand substantially perpendicular to a longitudinal axis extending thelength of the card. The first and second slots can terminate at alocation that is substantially centered between the first and secondsidewalls, with the second slot being disposed closer to the second endthan is the first slot. In some embodiments, a third slot can also beincluded. The third slot can be disposed closer to the second end thanis the second slot, and can be defined by three separate portions thatare in communication with each other to form the slot. A first portionof the slot can extend from the first sidewall; a second portion of theslot, which is adjacent to and in communication with the first portion,can be substantially V-shaped with a vertex facing the first end; and athird portion of the slot, which is adjacent to and in communicationwith the second portion, can be substantially parallel to the first andsecond slots.

Additional features can be formed in the card that can assist inpreventing premature and mistaken detachment of the suture from thecard. One such feature can be a catch slot formed in the body. The catchslot can extend from the first portion of the third slot, toward thesecond sidewall, and inward of a base of the V-shaped second portion.Another such feature can be a notch formed in the first sidewall, thenotch being disposed between the second and third slots. A third suchfeature can be a raised surface formed on the first surface of the bodybetween the second and the third slots.

Features to assist in placing the card in a handle of an insertion toolcan also be included on the card. For example, a protrusion can beformed on the second surface of the body. The protrusion can beconfigured to engage a complementary retention feature of an insertiontool to secure the device in the tool.

In some embodiments the card can be pre-loaded with a suture. The suturecan have a sliding knot formed therein. On one side of the sliding knotcan be a collapsible loop, while on the other side of the sliding knotcan be first and second free limbs. The collapsible loop can be heldopen by the first end of the suture management card, and the first andsecond free limbs can be disposed in the plurality of adjacent slotsformed in the body of the card.

One exemplary embodiment of a surgical implant system includes animplant inserter device, a suture having a collapsible loop defined by asliding knot and first and second free limbs extending on a side of thesliding knot opposite the collapsible loop, and a suture management cardconfigured to hold open the collapsible loop until a force applied tothe loop is greater than a threshold tension. The inserter device canhave a handle and a shaft extending distally from the handle, with aslot formed in the handle. The slot can be configured to receive thesuture management card, while the distal end of the shaft can beconfigured to engage a surgical implant. The suture management card canbe configured to be selectively inserted in and removed from the handleslot. The card can also be configured such that when it is removed fromthe handle slot, the first and second free limbs of the suture areaccessible and capable of being disposed through an opening of thecollapsible loop held open by the card so that the free limbs can beused to apply a force to the loop.

In some embodiments, the suture management card can include a first endconfigured to hold open the collapsible loop until a force applied tothe loop is greater than the threshold tension, a second end having anopening formed therein and configured to receive a distal portion of thefirst and second free limbs, and first and second sidewalls extendingbetween the first and second ends. The opening formed in the second endcan extend from the second sidewall and toward the first sidewall,terminating prior to the first sidewall. Other configurations of theopening are also possible.

The handle can include first and second suture-receiving slots formed ina distal end thereof. Each slot can be configured to receive the firstand second free limbs that extend distally from the sliding knot on theside opposite of the collapsible loop. The second suture-receiving slotcan further include a pinch point formed in a portion thereof. The pinchpoint can be configured to engage the first and second free limbs fromopposed sides when the suture management card is disposed in the handle.Further, the pinch point can be configured to release the first andsecond free limbs when the suture management card is removed from theslot formed in the handle.

The system can also include a surgical implant. The implant can haveproximal and distal ends, with the proximal end having a bore formedtherein and the distal end having a filament engagement featureconfigured to receive the first and second free limbs. The proximal endcan be coupled to the distal end of the shaft of the inserter tool viathe bore. In some embodiments, the first and second free limbs of thefilament can be disposed through the implant's bore at the proximal end,around the implant's filament engagement feature at its distal end, andback through the implant's bore before exiting out of the bore at theproximal end.

One exemplary embodiment of a surgical method includes implanting ananchor having a suture coupled thereto at a surgical site using aninsertion tool. The insertion tool can have a suture management cardremovably disposed in a portion thereof, and a collapsible loop of thesuture can be held open by the card. A sliding knot formed in the suturecan define the collapsible loop. The method can further include removingthe suture management card from the handle and grasping a free limb(s)of the suture that is disposed on a side of the sliding knot oppositethe collapsible loop. Depending on the configuration of the card, thefree limb(s) may fall away from the card as the card is removed, whilein other embodiments the surgeon can disassociate the free limb(s) fromthe card. The surgeon can then position a distal end of the free limb(s)in an opening of the collapsible loop that is maintained by the suturemanagement card. For example, the free limb(s) can be folded over aroundthe collapsible loop, and a force can subsequently be applied to thefree limb(s). The force can be sufficient to disengage the collapsibleloop from the suture management card. Subsequently, the free limb(s) canbe decoupled from the suture management card, after which tension can beapplied to the free limb(s) to collapse the sliding knot. Theapplication of tension can also be suitable to advance the knot towardthe surgical site to secure tissue to bone, for instance after the knotis fully collapsed.

In some embodiments, the method can include inserting the suturemanagement card into the insertion tool to secure a distal portion ofthe free limb(s) in the insertion tool during implantation of the sutureanchor. In some other embodiments, the step of decoupling the freelimb(s) from the suture management card can include applying tension tothe free limb(s) in a direction approximately perpendicular to asidewall of the suture management card. Doing so can free the freelimb(s) from one or more resistance features of the suture managementcard.

In another exemplary embodiment of a surgical method, the method caninclude inserting a suture to a surgical location using an insertiondevice. During insertion, the suture can be coupled to a suturemanagement card that is removably and replaceably disposed in theinsertion device. The suture can have a looped end extending from oneside of a knot that defines the loop attached to the card and a distalportion that extends from the other side of the knot. When the card isremoved from the insertion device, both the looped end and the distalportion of the suture can also be removed from the insertion device. Thesuture can subsequently be removed from the card and used to completethe surgical procedure, for instance by using the suture to hold atissue at a desired location with respect to bone. In some embodiments,prior to removing the suture from the card, distal ends of the distalportion can be passed through the looped portion, and a force can beapplied to the distal portion to eject the looped portion from the card.The looped portion can be collapsed and drawn toward bone to secure alocation of tissue with respect to bone.

BRIEF DESCRIPTION OF DRAWINGS

This invention will be more fully understood from the following detaileddescription taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 is a perspective top view of one exemplary embodiment of a systemfor soft tissue repair, including an inserter tool and two differentexemplary embodiments of a suture management card, the first suturemanagement card being located to the right of the second suturemanagement card;

FIG. 2 is a perspective view of a handle of the inserter tool and thefirst suture management card of FIG. 1;

FIG. 3A is a top perspective view of a first surface of the first suturemanagement card of FIG. 1;

FIG. 3B is a top perspective view of the first surface of FIG. 3A havinga suture attached to the suture management card;

FIG. 3C is a side perspective view of a first sidewall of the firstsuture management card of FIG. 3A;

FIG. 3D is another side perspective view of the first sidewall of FIG.3C;

FIG. 3E is a side perspective view of a second sidewall of the suturemanagement card of FIG. 3A;

FIG. 3F is a top perspective view of a first end and a second surface ofthe suture management card of FIG. 3A;

FIG. 3G is a top perspective view of the first end and the first surfaceof the suture management card of FIG. 3A;

FIG. 3H is a bottom perspective view of a second end of the suturemanagement card of FIG. 3A;

FIG. 3I is a top perspective view of the second surface of the suturemanagement card of FIG. 3B;

FIG. 3J is a bottom perspective view of the second surface of the suturemanagement card of FIG. 3B, with the suture passing through a thru-holeof the second end;

FIG. 3K is a top perspective view of the first surface of the suturemanagement card of FIG. 3J;

FIG. 3L is a bottom perspective view of the second surface of the suturemanagement card of FIG. 3A;

FIG. 4 is a top perspective view of the handle of FIG. 2;

FIGS. 5-6 are sequential views illustrating one exemplary embodiment forinstalling the suture management card of FIG. 3L into the handle of FIG.4;

FIG. 7A is a schematic view of one exemplary embodiment for forming asliding knot in a suture;

FIG. 7B is a top perspective view of the suture and sliding knot of FIG.7A;

FIG. 7C is a perspective view of one exemplary embodiment of collapsingthe sliding knot of FIG. 7B;

FIGS. 7D-7I are sequential views illustrating one exemplary embodimentfor installing the suture of FIG. 7C onto the first suture managementcard of FIG. 1;

FIG. 8 is a top perspective view of the second suture management card ofFIG. 1;

FIG. 9 is a top perspective view of the suture management card of FIG.8, illustrating a raised portion formed thereon;

FIG. 10 is a side perspective view of the suture management card of FIG.8, illustrating a catch slot formed therein;

FIG. 11 is a side perspective view of the suture management card of FIG.8, illustrating a boot notch formed therein;

FIG. 12 is a top perspective view of the inserter tool of FIG. 1 and thesuture management card of FIG. 8;

FIG. 13 is a perspective view of a distal end of a shaft of the insertertool of FIG. 1;

FIG. 14A is a perspective view of the distal end of the shaft of FIG. 13coupled to an anchor having a suture filament disposed therein;

FIG. 14B is a cross-sectional view of the shaft, anchor, and suturefilament of FIG. 14A taken along the line B-B;

FIG. 15 is a schematic view of the anchor and suture filament of FIG.14A implanted in bone, with the suture filament passing through softtissue;

FIGS. 16A-16D are sequential views illustrating one exemplary embodimentfor removing the suture management card of FIG. 5 from the handle ofFIG. 2;

FIGS. 17A-17I are sequential views illustrating one exemplary embodimentfor removing suture from the suture management card of FIG. 3A; and

FIGS. 18A-18D are sequential views illustrating one exemplary embodimentfor using the suture filament of FIG. 15 to secure soft tissue to bone.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention. By way of non-limiting example, featuresdescribed with respect to one suture management card can generally beapplied to the other card configurations provided for herein. Further,in the present disclosure, like-numbered components of the embodimentsgenerally have similar features. Still further, sizes and shapes of thesystems and devices, and the components thereof, can depend at least onthe anatomy of the subject in which the systems and devices will beused, the size and shape of components with which the systems anddevices will be used, and the methods and procedures in which thesystems and devices will be used.

The figures provided herein are not necessarily to scale. Further, tothe extent arrows are used to describe a direction a component can betensioned or pulled, these arrows are illustrative and in no way limitthe direction the respective component can be tensioned or pulled. Aperson skilled in the art will recognize other ways and directions forcreating the desired tension or movement. Likewise, while in someembodiments movement of one component is described with respect toanother, a person skilled in the art will recognize that other movementsare possible. By way of non-limiting example, in embodiments in which asliding knot is used to help define a collapsible loop, a person skilledin the art will recognize that different knot configurations can changewhether moving the knot in one direction will cause a size of an openingdefined by the loop to increase or decrease. Additionally, a number ofterms may be used throughout the disclosure interchangeably but will beunderstood by a person skilled in the art. By way of non-limitingexample, the terms “suture” and “filament” may be used interchangeably.

The present disclosure generally relates to a surgical suture managementdevice used to assist surgeons in managing suture filaments during asoft tissue repair procedure. The filament, which is typically attachedto an anchor implanted in bone, can have multiple limbs that the surgeonmust manage during anchor implantation. The surgeon then uses the limbsto draw soft tissue coupled thereto toward the bone in which the anchoris implanted and subsequently secure the tissue at a location proximateto the bone. The management device can be removably included in a handleof an anchor insertion tool, and can include a number of features toassist a surgeon with suture filament management throughout the surgicalprocedure.

Two exemplary embodiments of suture management devices are illustratedin FIG. 1 as a first suture management card 10 and a second suturemanagement card 10′. The cards 10, 10′ can be adapted to fit into acomplementary slot 92 formed in a handle 90 of an inserter tool 80. Wheneither of the suture management cards 10, 10′ is disposed in the handle90, limbs of a suture filament attached thereto can extend distallyalong a shaft 82 of the inserter tool 80, be coupled to an anchor 100coupled to a distal end 82 d of the shaft 82, extend proximally back upthe shaft 82, and be coupled to the handle 90.

FIG. 2 illustrates one exemplary embodiment of the handle 90 of insertertool 80. The handle 90 is adapted to receive one of the suturemanagement cards 10, 10′ (such as card 10 shown in FIG. 2) in its slot92. Further, the handle 90 can include two suture-receiving slots 94, 95for receiving limbs of suture extending proximally from an anchor, asdescribed in further detail below. Additionally, a cut-out portion 96can be formed in a portion of the handle 90 to assist with insertion andremoval of the card 10. The cut-out portion 96 allows a portion of theinserted card 10 to be exposed, which in turn makes it easier for asurgeon to grasp the card 10 to remove it from the handle 90. After theanchor is inserted into bone, the suture management card 10 can beremoved from the handle 90, the suture can be disassociated from thecard 10, and the suture can be used to draw tissue to the bone in whichthe anchor is inserted using techniques known to those skilled in theart.

FIGS. 3A-3L illustrate the first exemplary embodiment of a suturemanagement card 10. The card 10 can generally have a substantiallypolygonal shape (e.g., a rectangular shape) with a proximal or first end12 and a distal or second end 14 that define a length L of the card 10(FIG. 3A), a first sidewall 16 and a second sidewall 18 extendingbetween the first and second ends 12, 14 that define a width W of thecard 10 (FIG. 3A), and a first surface 20 and a second surface 22 (FIG.3D) that define a thickness T of the card 10 (FIG. 3C). As shown inFIGS. 3A and 3B, the card 10 can be trapezoidal in shape, with the widthW gradually increasing from the second end 14 to the first end 12. Inthe illustrated embodiment, the gradual increase of the width Wcoincides with a gradual increase in the diameter of the inserter toolhandle 90 in which the card 10 is disposed so that the card 10 can sitapproximately flush within the handle 90 along a substantial length ofthe card 10. As shown in FIGS. 3C and 3D, the card 10 can also havedifferent thicknesses T at various locations between the first andsecond ends 12, 14. In the illustrated embodiment, the thickness T at aterminal end of the first sidewall 16 at the first end 12 and at aterminal end of the first sidewall 16 at the second end 14 issubstantially similar, with the thickness T decreasing between theterminal ends and a central portion of the sidewall 16. As shown in FIG.3E, a thickness T of the second sidewall 18, on the other hand, canremain substantially the same along its length.

A size and shape of the suture management card 10, as well as thematerials from which it is made, can depend, at least in part, on thesizes, shapes, and materials with which it will be used, including thesuture filament and inserter tool, and the type of procedure with whichit will be used. Accordingly, to the extent the present disclosuredescribes the card 10 as being polygonal, such as substantiallyrectangular or trapezoidal, other shapes can also be used withoutdeparting from the spirit of the disclosure. In some exemplaryembodiments of the card, a length L can be in the range of about 3centimeters to about 8 centimeters, a width W can be in the range ofabout 1 centimeter to about 4 centimeters, and a thickness T can be inthe range of about 0.5 millimeters to about 6 millimeters. In oneexemplary embodiment the card has a length L of about 4.5 centimeters, awidth W at the second end of about 2.0 centimeters, a width W at thefirst end of about 2.5 centimeters, a thickness T at the terminal endsof the first and second sidewalls 16, 18 of about 3.0 millimeters, and athickness T at central portions of the first and second sidewalls 16, 18of about 1.0 millimeters and about 3.0 millimeters, respectively. Anynumber of materials can be used to form the card, including polymers andmetals, but in one exemplary embodiment the card is made ofpolycarbonate.

The first end 12 can be configured to hold open a collapsible loop 52 ofsuture filament 50, as shown in FIG. 3B. The loop 52 can be defined by aknot 56 formed in the suture filament 50, and one or more limbs 54, 55can extend distally from the knot 56. The second end 14 can include anopening 26 configured to receive a distal portion of the filament limbs54, 55, as shown in FIGS. 3J and 3K. As described herein, the filament50 extends from the card 10, to an anchor, and back to the card 10, withthe distal portion being a portion of the limbs 54, 55 extendingproximally toward the card 10 from an anchor. A plurality of adjacentslots 24 can be formed in the card 10, between the first and second ends12, 14, to receive a portion of the limbs 54, 55 that extend distallyfrom the knot 56, as shown in FIGS. 3B, 3I, 3J, and 3K.

Turning to more particular features of the suture management card 10,the first end 12 can include first and second prongs 30, 32, which areshown at least in FIGS. 3A and 3B. The prongs 30, 32 can be configuredto hold open the collapsible loop 52 of suture 50 until a force appliedto the loop 52 is greater than an ejection threshold tension created bythe prongs 30, 32 and adjacent slots 24. It can be useful to maintain anopening of the loop 52 during shipping, and also during a surgicalprocedure at least until the loop 52 is collapsed. The prongs 30, 32 canhave a variety of shapes, but in the illustrated embodiment they extendfrom the first end 12, a distance beyond the length L, and are polygonalin shape. In some embodiments the prongs 30, 32 can be angled withrespect to an axis Q extending along the width W of the card 10. Anangle α (FIG. 3A) formed by the prongs 30, 32 with respect the axis Qcan be in the range of about 90 degrees to about 110 degrees, and in theillustrated embodiment the angle α is approximately 97 degrees. Theprongs 30, 32, along with a portion of the first end 12, define anopening 34 for receiving a distal portion of the suture limbs 54, 55.The distal portions can be passed into the opening 34, and wrappedaround the loop 52, to subsequently apply a tension that exceeds theejection threshold tension, thereby ejecting the loop 52 off the card10, as described in further detail below. A space 31 located between theprongs 30, 32, and in communication with the opening 34, allows thedistal portions to pass therethrough to move away from the card whenejecting the loop 52.

As shown in FIGS. 3E-3G, a thickness t of the prongs 30, 32 can be lessthan the thickness T of the first end 12 from which they extend. As aresult, shoulder 36 on which the suture filament can be seated whenwrapped around the prongs 30, 32 is formed on the second surface 22 ofthe card 10, as shown in FIG. 3F. In the illustrated embodiment theshoulder 36 extends a small distance beyond the length L of the card 10.The reduced thickness t of the prongs 30, 32 also allows grooves ortracks 38 to be formed on the first surface 20 of the card 10, as shownin FIG. 3G, on which the filament forming the loop 52 can sit, as shownin FIG. 3B. The grooves or tracks 38 can extend diagonally from thefirst end 12, toward the second end 14, and meet at a vertex 39substantially centered between the first and second sidewalls 16, 18.The grooves 38 can be in communication with a longitudinal seatinggroove 40 formed on the first surface 20 of the card 10, which itselfcan be configured to receive the knot 56 of the collapsible loop 52. Thedepths of the grooves 38 and the longitudinal seating groove 40 can besuch that the any exposed portions of the suture 50 or knot 56 do notsit proud above the first surface 20, and thus are not easily chafed orfrayed by contact with an outside object.

Below the longitudinal seating channel 40 are a plurality of slots 24that work in harmony, along with the prongs 30, 32, to apply tension tothe free limbs 54, 55 of suture filament extending from the knot 56 sothat only a tension force that exceeds the ejection threshold tensioncan eject the loop 52 from the prongs 30, 32 of the suture managementcard 10. As shown, there is a first slot 24 a, a second slot 24 b, and athird slot 24 c, each of which is formed in the first sidewall 16 andextends toward the second sidewall 18. The first and second slots 24 a,24 b can be substantially parallel to each other and substantiallyperpendicular to a longitudinal axis M (FIG. 3A) extending the length ofthe card 10, with the second slot 24 b being disposed closer to thesecond end 14 than is the first slot 24 a. The third slot 24 c can bedisposed closer to the second end 14 than is the second slot 24 b, andcan include three separate portions that are in communication with eachother. As shown, a first portion 24 c ₁ of the third slot 24 c canextend from the first sidewall 16 and toward the second sidewall 18,while being substantially parallel to the first and second slots 24 a,24 b. A second portion 24 c ₂ of the third slot 24 c can be adjacent toand in communication with the first portion 24 c ₁, and it can besubstantially V-shaped with a vertex facing the first end 12. A thirdportion 24 c ₃ of the slot 24 c can be adjacent to and in communicationwith the second portion 24 c ₂, and like the first portion 24 c ₁ can besubstantially parallel to the first and second slots 24 a, 24 b.

The first, second, and third slots 24 a, 24 b, and 24 c can eachterminate substantially in the center of the card 10 between the firstand second sidewalls 16, 18. As shown, they define first and seconddeflectable tangs 28, 29, which can deflect above and below a planeextending through the card 10 that is substantially parallel to thefirst and second surfaces 20, 22. Because the slots 24 a, 24 b, 24 cterminate substantially approximately at the center of the card betweenthe first and second sidewalls 16, 18, the filament limbs 54, 55extending from the knot 56 in the longitudinal seating groove 40 can bedisposed in the slots 24 a, 24 b, 24 c by extending in a substantiallystraight direction from the knot 56. The limbs 54, 55 can be selectivelypassed through the slots 24 a, 24 b, 24 c to apply a frictionalresistance to tension. For example, as shown in FIG. 3B, the filamentlimbs 54, 55 are passed from the longitudinal passageway 40, through thefirst slot 24 a to the second surface 22 of the card 10, through thesecond slot 24 b back to the first surface 20, and through the thirdslot 24 c back to the second surface 22. In this configuration, theV-shaped second portion 24 c ₂ of the third slot 24 c can help keep thefilament limbs 54, 55 from inadvertently being dislodged from the thirdslot 24 c because a different angle of tension is needed to work thelimbs 54, 55 through the third portion 24 c ₃, over the vertex of theV-shaped second portion 24 c ₂, and then out of the first portion 24 c ₁to disassociate those portions of the limbs 54, 55 with the suturemanagement card 10.

The ejection threshold tension is the amount of force that must beexceeded to eject the loop 52 from the prongs 30, 32. A force in excessof the ejection threshold tension is generally applied to the loop 52itself. The magnitude of the ejection threshold tension of the card 10can principally be controlled by the configuration of the plurality ofslots 24 and the suture 50 associated therewith. The configuration ofthe prongs 30, 32, such as the value of the angle α, can also affect theejection threshold tension. The ejection threshold tension should be avalue that will not generally be achieved by the application of anincidental force to the loop 52 during use. Preferably, only apurposeful application of force to the loop 52 should be sufficient toeject it from the prongs 30, 32. In some exemplary embodiments theejection threshold tension can be in the range of about 3 Newtons toabout 8 Newtons, and in one embodiment the threshold tension is about5.5 Newtons. In other embodiments of a suture management card, a loop ofsuture can dislodge or eject from a card in a different manner thandescribed above, for instance by including a sliding feature on the cardthat permits a user to eject the suture by sliding it off the card. Aperson skilled in the art will recognize that other techniques orfeatures for disassociating the loop from the card can be adapted foruse with the teachings provided herein, and that including suchtechniques or features on the card does not depart from the spirit ofthe present disclosure and the values described herein, e.g., theejection threshold tension, can be adapted to apply to the appropriatefeatures of the card. For example, a person skilled in the art willrecognize the appropriate ejection threshold tension to use to remove asuture from a card in which the suture is designed to slide off the cardafter the ejection threshold tension is exceeded.

A collapsing threshold tension also exists, as discussed with moreparticularity with respect to FIGS. 17D and 17E. The collapsingthreshold tension is the tension that, if exceeded, collapses the loop52. A force in excess of the collapsing threshold tension is generallyapplied to the loop 52 to collapse it. The magnitude of the collapsingthreshold tension of the card 10 can principally be controlled by theconfiguration of the plurality of slots 24, i.e., via friction throughthe slots 24, and the suture associated therewith. Its magnitude isgenerally greater than the ejection threshold tension and greater than adrag force of the knot 56 on the limbs 54, 55 running through it,thereby ensuring that the knot 56 collapses before the suture 50 slidesthrough the slots 24. In some exemplary embodiments the collapsingthreshold tension can be in the range of about 6 Newtons to about 15Newtons, and in one embodiment the collapsing threshold tension is about9 Newtons.

As shown in FIG. 3H, a slot 42 can be formed in the second surface 22 ofthe terminal end of the second end 14 to receive the limbs 54, 55extending from the last slot 24 c. The slot 42 can also receive portionsof the limbs 54, 55 disposed in a sleeve 58 when a sleeve 58 returnsback toward the card 10 after being coupled to an anchor, as describedbelow. The slot 42 protects the limbs 54, 55 and sleeve 58 fromextending substantially above the second surface 22 as the thickness Tof the first sidewall 16 increases while approaching the second end 14.Thus, as shown in FIG. 3I, the limbs 54, 55 can sit against the secondsurface 22, within the slot 42, and be protected against unintendedfraying or chafing. In the illustrated embodiment, the slot 42 extendsbetween a substantial center portion of the card 10, toward the secondsidewall 18, terminating prior to the second sidewall 18, although otherconfigurations and locations are possible without departing from thespirit of the disclosure. In some embodiments, the slot 42 can receivean initial portion of the limbs 54, 55 that extend from the third slot24 c, as illustrated in FIG. 3I, and it can also receive a distalportion of the limbs 54, 55 that return from an anchor, as illustratedin FIG. 3J. In some embodiments, the limbs 54, 55 can be disposed in asleeve 58 when they pass through the slot 42, as described below.

An opening 26 proximal of the slot 42 can be formed adjacent the secondend 14. The opening 26 can be configured to receive the distal portionof the filament limbs 54, 55 that return to the card 10 after firstbeing coupled to an anchor. In the illustrated embodiment, the opening26 is a thru-hole that extends between the first and second surfaces 20,22, substantially centered between the first and second sidewalls 16,18. As shown in FIGS. 3J and 3K, the distal portion of the filamentlimbs 54, 55 can pass through the opening 26. These limbs 54, 55 can beretained in a handle of an inserter tool when the card 10 is disposed inan inserter tool, and can be accessible by the surgeon when the card 10is removed from the inserter tool, as described in further detail below.

The first and second surfaces 20, 22 of the card 10 can include a numberof different features to assist a surgeon in using the card 10, forinstance by helping to prevent the misuse of the card by disassociatingportions of suture filament from the card earlier than desired. As shownin FIGS. 3A and 3B, some of these features include a raised surface 44,a catch slot 46, and a boot notch 48, the purposes of which aredescribed below in greater detail with respect to the second suturemanagement card 10′ and shown in FIGS. 8-11. Optionally, one or moreraised ridges 49 can be formed on one of the first or second surfaces20, 22 of the card 10. In the illustrated embodiment, four raised ridges49 are formed on the first surface 20 between the third slot 24 c andthe thru-hole 26, with the ridges 49 having a decreasing arc length andan increasing radius of curvature as they approach the distal end 14 ofthe card 10. As shown, the distal-most raised ridge 49 can have a radiusof curvature that substantially tracks the arc of the opening 26. Theraised ridges 49 can improve a surgeon's grip on the card 10 when thecard 10 is being held by the surgeon during ejection of the loop 52 andthe subsequent disassociation of the suture filament 50 from the card10. Additionally, in instances in which the ridges 49 are formed only onone of the two surfaces 20, 22, the ridges 49 can help a surgeondistinguish between the first and second sides of the card 10 by tactilefeedback.

Features to assist with insertion of the card into an inserter tool canalso be included on the first and second surfaces 20, 22. As shown inFIG. 3L, the second surface 22 can include a protrusion 47 formedthereon. The protrusion 47 can be any shape or size, but in theillustrated embodiment it is a raised hemispherical portion formed onthe second surface 22. The protrusion 47 can be configured to becomplementary to a retention feature located within the slot 92 of thehandle 90 of the inserter tool 80 to form a snap fit. FIG. 4 illustratesone such complementary retention feature 97. The retention feature 97 isa rectangular boss having two chamfered edge surfaces 97 a, 97 b. Theboss 97 can be disposed in the slot 92 at a location such that when theprotrusion 47 passes the second chamfer 97 b, the second sidewall 18 issubstantially flush with the handle 90.

As shown in FIGS. 5 and 6, as the card 10 is inserted into the handle90, the protrusion 47 slides over the first chamfer 97 a and to thesecond chamfer 97 b to secure the card 10 in the slot 92. When theprotrusion 47 passes the second chamfer 97 b, an audible sound canoptionally provide feedback to the surgeon to confirm that the card 10is secured in the handle 90. As the card 10 is pulled out of the handle90, the protrusion 47 slides back over the second chamfer 97 b, past thefirst chamfer 97 a, and out of the handle 90.

A variety of different suture filaments having different features andfunctions can be used in association with suture management carddisclosed herein. One skilled in the art will appreciate that suchsutures can be made of a variety of suitable materials. Moreover, thesuture filaments can be of different types, including but not limited toa cannulated filament, a braided filament, and a mono filament. Thetype, size, and strength of the filament can depend, at least in part,on the other materials of the system, including the material(s) of thesuture management card, the tissue and other components through which itwill be passed or coupled to, and the type of procedure in which it isused. As shown in FIG. 3B, in one exemplary embodiment, the suturefilament 50 has a sliding knot 56 formed therein that defines acollapsible loop 52. The loop is formed from first and second limbs 54,55 of the filament 50. Extending from the side of the knot 56 oppositethe loop 52 can be first and second suture free filaments limbs 54, 55.These are “free” limbs because they are not the portion of the limbs 54,55 that forms the loop 52. A person skilled in the art will recognize anumber of different by which the sliding knot 56, and resulting loop 52and free limbs 54, 55, can be formed. By way of non-limiting example,the knot 56 can be a Buntline Hitch, a Tennessee slider, a Duncan Loop,or a Hangman's Noose.

In one exemplary embodiment the filament is a #0 filament (about 26gauge to about 27 gauge), such as an Orthocord™ filament that iscommercially available from DePuy Mitek, LLC, 325 Paramount Drive,Raynham, Mass. 02767, or an Ethibond™ filament that is commerciallyavailable from Ethicon, Inc., Route 22 West, Somerville, N.J. 08876. Thethickness of the filament should provide strength in the connection butat the same time minimize the trauma caused to tissue through which itpasses. In some embodiments the filament can have a size in the range ofabout a #5 filament (about 20 gauge to about 21 gauge) and about a #5-0filament (about 35 gauge to about 38 gauge). Orthocord™ suture isapproximately fifty-five to sixty-five percent PDS™ polydioxanone, whichis bioabsorbable, and the remaining thirty-five to forty-five percentultra high molecular weight polyethylene, while Ethibond™ suture isprimarily high strength polyester. The amount and type of bioabsorbablematerial, if any, utilized in the filaments of the present disclosure isprimarily a matter of surgeon preference for the particular surgicalprocedure to be performed.

Optionally, a flexible sleeve can be provided for encapsulating at leasta portion of the first and second suture filament limbs 54, 55. Althoughnot illustrated in FIGS. 3A-3J, FIG. 13 illustrates a sleeve 58 disposedaround a portion of the filament limbs 54, 55 that extends distally fromthe knot 56. In one exemplary embodiment, the sleeve begins at alocation of the filament limbs 54, 55 that extends distally along theinserter tool shaft 82 prior to the limbs 54, 55 reaching the anchor100, and then covers the remaining portions of the limbs 54, 55 suchthat terminal ends of the limbs 54, 55 terminate before the terminal endof the sleeve 58. The sleeve can assist in managing the filament limbs54, 55 as they pass through and around the anchor 100, proximally up theshaft 82 of the inserter tool 80, back into the suture management card10, and into the handle 90 of the inserter tool 80. Additionally, thesleeve 58 can be configured to have a smooth surface so that it caneasily pass through tissue, thus easing trauma caused by passing theconstruct through tissue. The sleeve can be removable, and can beremoved at any desired during time during a repair procedure.

The sleeve can be made from a wide variety of biocompatible flexiblematerials, including a flexible polymer or it can be another filament.In one embodiment, the sleeve is made of a polymeric material. Inanother embodiment, the sleeve is a flexible filament, such as a braidedsuture, for example Ethibond™ filament or Orthocord™ #2 filament, whichis typically braided at sixty picks per 2.54 centimeters. For use as asleeve, a more relaxed braid of approximately thirty to forty picks per2.54 centimeters is preferred, more preferably about 36 picks per 2.54centimeters. If the sleeve material is formed about a core, preferablythat core is removed to facilitate insertion of the filament limbs,which may themselves be formed of typical suture such as Orthocord™ #0suture or #2 suture braided at sixty picks per 2.54 centimeters.Additional convenience can be provided by perceptible indicators on thesleeve such as different markings, colors, diameters, braid or designpatterns, or other tactile or visual indicia, especially if multipletissue attachments or anchors are utilized.

A sliding knot can be formed in a filament to define a loop using avariety of techniques known to those skilled in the art, including butnot limited to forming a Buntline Hitch, a Tennessee slider, a DuncanLoop, or a Hangman's Noose. As shown in FIGS. 7A and 7B, a filament 50′can be folded approximately in half and can have a double over-hand knot52′ formed therein. Tails 54′, 55′ of the filament 50′ can be passedthrough the knot 52′ to form a loop 56′. The knot 52′ can then betightened around the tails 54′, 55′ to form the collapsed sliding knot52′ using a variety of techniques known to those skilled in the art. Inone exemplary embodiment, illustrated in FIG. 7C, a dowel 51′ or otherobject can be disposed in the loop 56′ to prevent the loop 56′ fromfully collapsing when a force in a direction J is applied to the tails54′, 55′. As a result, when the force in the direction J is applied tothe tails 54′, 55′, the knot 52′ collapses, resulting in the loop 56′extending from one side of the knot 52′ and the tails 54′, 55′ extendingfrom the other side of the knot 52′.

The filament 50′ having the loop 56′ and tails 54′, 55′ can be attachedto a suture management card. FIGS. 7D-7I illustrate one exemplaryembodiment of coupling the filament 50′ to the first suture managementcard 10. As shown in FIG. 7D, the loop 56′ can be placed around theprongs 30, 32 to create an initial attachment point between the filament50′ and the card 10. A force in a direction K can be applied to thetails 54′, 55′ to tighten the loop 56′ around the prongs 30, 32, asshown in FIG. 7E. As the loop 56′ tightens, the filament 50′ can bemanipulated so that the loop 56′ sits in the grooves 38 and the knot 52′sits in the longitudinal seating groove 40, thereby reducing the risk ofthe filament 50′ chafing or fraying.

As shown in FIG. 7F, the tails 54′, 55′ can then be disposed in theslots 24. The tails 54′, 55′ can first be disposed in the first slot 24a, passing from the first surface 20 toward the second surface 22. Inone embodiment the tails 54′, 55′ are slid to a terminal end of the slot24 a so that the filament 50′ extends approximately in-line with thelongitudinal channel 40 of the card 10. As shown in FIG. 7G, the tails54′, 55′ can then be disposed in the second slot 24 b, passing from thesecond surface 22 toward the first surface 20. The tails 54′, 55′ can beslid to a terminal end of the slot 24 b so that the filament 50′continues to extend in an approximately straight configuration from thelongitudinal channel 40.

As shown in FIG. 7H, the tails 54′, 55′ can extend adjacent to andbehind the raised surface 44 and can be passed into the third slot 24 c.The tails 54′, 55′ once again extend from the first surface 20 andtoward the second surface 22, and they can be manipulated through thethird slot 24 c so as not to get caught in the catch slot 46 and so theypass up and over the second, V-shaped portion 24 c ₂ of the third slot24 c. As shown in FIG. 71, the tails 54′, 55′ can be slid to a terminalend of the slot 24 c, again allowing the filament 50′ to continue toextend in an approximately straight configuration from the longitudinalchannel 40. Further, because the filament 50′ is disposed adjacent toand behind the raised surface 44, the raised surface 44 can be effectiveto prevent unintentional off-loading of the filament 50′ from the card10, as described below with respect to FIG. 9. With the filament 50′coupled to the card 10, the filament 50′ and card 10 can be used inmanners consistent with the descriptions contained herein. A personskilled in the art will understand how these same steps for associatinga filament with a suture management card can be adapted for use with thesuture management card 10′.

FIGS. 8-11 illustrate the second exemplary embodiment of a suturemanagement card 10′. This second suture management card 10′ has manysimilar features to that of the first suture management card 10. It canhave a substantially polygonal shape, as shown a trapezoidal shape, witha proximal or first end 12′ and a distal or second end 14′, a firstsidewall 16′ and a second sidewall 18′ extending between the first andsecond ends 12′, 14′, and a first surface 20′ and a second surface 22′(not shown). The size and shape of the card 10′, as well as thematerials used to make the card 10′, can be substantially similar tothat of the first card 10. For example, a width and thickness of thesecond card 10′ can vary over portions of a body of the card 10′ in amanner similar to as described with respect to the card 10.

The suture management card 10′ can also include many of the samefeatures as the suture management card 10, including first and secondprongs 30′, 32′ for holding open a loop 52 of suture filament 50,grooves 38′ and a shoulder 36′ (not shown) along which a length of thefilament loop 52 can be disposed, a longitudinal seating channel 40′ inwhich a knot 56 formed in the suture filament 50 can be disposed, aplurality of slots 24′ (24 a′, 24 b′, 24 c′) disposed distal of thelongitudinal seating channel 40′ for applying tension to free limbs 54,55 of suture filament 50 extending from the knot 56, and first andsecond deflectable tangs 28′, 29′ formed by the slots 24′. Additionalfeatures of the card 10′ that are similar to features in the card 10include a slot 42′ (not shown) formed in the terminal end of the secondend 14′ to receive filament limbs 54, 55 extending from the last slot 24c′, an opening 26′ proximal of the slot 42′ for receiving a distalportion of the filament limbs 54, 55 that return to the card 10′ afterfirst being coupled to an anchor, and features to assist a surgeon inusing the card, including a raised surface 44′, a catch slot 46′, a bootnotch 48′, ridges 49′ formed on a first surface 20′ of the card 10′, anda protrusion 47′ (not shown) formed on the second surface 22′ to assistwith insertion of the card 10′ into an inserter tool. While many ofthese features have similar configurations as their equivalent featuresof the suture management card 10, some differences are described below.A person having skill in the art will recognize that these differencescan be interchangeably incorporated into the two suture management cards10, 10′, or other similar devices, without departing from the spirit ofthe present disclosure.

The grooves or tracks 38′ formed in the first end 12′ of the card 10′and extending diagonally from the first end 12′ and toward the secondend 14′ are different than the grooves 38 of card 10 in that thesegrooves 38′ extend deeper into the first surface 20′. Ridges and bossesare included along the path where the suture filament 50 runs, whichmakes it more difficult to pull the filament 50 out of the grooves 38′and mistakenly pull the loop 52 off the prongs 30′, 32′. Thisconfiguration generally prevents a surgeon from using his or her fingerto access the filament 50 disposed in the grooves 38′ and thus thefilament 50 typically exits the grooves 38′ only after a force greaterthan the ejection threshold tension is applied to eject the loop 52 fromthe prongs 30′, 32′. Similar to the grooves 38 of the card 10, thegrooves 38′ are in communication with the longitudinal seating groove40′, which can receive the sliding knot 56 formed in the suture filament50.

While the second suture card 10′ includes an opening 26′ formed in thesecond end 14′, the opening 26′ is different than the opening 26 in thatit is an open-ended slot rather than a closed thru-hole. As shown, theopening 26′ is a slot formed in the second sidewall 18, extendingtowards the first sidewall 16, and terminating just short of a centerportion between the first and second sidewalls 16, 18. As described ingreater detail with respect to FIGS. 16A-16D, this design allows thedistal portion of the filament limbs 54, 55 to be readily accessed bythe surgeon without having to take a separate action to pull the distalportion of the filament limbs 54, 55 out of the opening.

The raised ridges 49′ formed on the first surface 20′ serve a similarpurpose as the raised ridges 49 of the card 10. They can improve asurgeons grip on the card 10′, and they can also help a surgeon easilyknow the difference between the two sides 20′, 22′ of the card 10′ basedon tactile feedback. The ridges 49′ in the illustrated embodimentinclude three substantially straight grooves that decrease in length asthey approach the distal end 14′.

Features designed to assist a surgeon in using the card 10′, and inparticular helping to prevent the misuse of the card 10′ bydisassociating portions of the suture filament 50 from the card 10′earlier than desired, are illustrated with particularity in FIGS. 9-11.FIG. 9 helps illustrate a benefit of the raised portion 44′ disposed onthe second deflectable tang 29′. The raised portion 44′ can have avariety of shapes, but in the illustrated embodiment it is apyramid-shaped ramp that increases in height from the second slot 24 b′to the third slot 24 c′. The raised portion 49′ can be raised withrespect to the first surface 20′ between about 0.5 to about 2millimeters, and in the illustrated embodiment a peak height of theraised portion 44′ is about 1 millimeter. As shown, when tension isapplied in an approximate direction A, the filament limbs 54, 55 areprevented from off-loading via the third slot 24 c′ because the raisedportion 44′ resists the tension. Instead the filament limbs 54, 55 areheld against the root of the third slot 24 c′.

FIG. 10 illustrates another feature of the suture management card 10′that helps prevent inadvertent off-loading of the suture. This featureis a catch slot 46′ formed in the body of the card 10′, extending off anentry way of the third slot 24 c′. As shown, the catch slot 46′ extendsfrom a first portion 24 c ₁′ of the third slot 24 c′, toward the secondsidewall 18′ (not shown), and inward of a base of a V-shaped secondportion 24 c ₂′ of the third slot 24 c′. When a surgeon brings thefilament limbs 54, 55 around from the second surface 22′ (not shown) ofthe body, over to the first surface 20′, and applies tension to thefilament limbs 54, 55 in an approximate direction B as shown, the catchslot 46′ is designed to catch the filament limbs 54, 55 and absorb theapplied tension. If the catch slot 46′ was not present, the force couldallow the filament limbs 54, 55 to slide over the V-shaped secondportion 24 c ₂′, to a third portion 24 c ₃′ of the third slot 24 c′, inwhich the filament limbs 54, 55 are disposed, and then the filamentlimbs 54, 55 could be removed from the third slot 24 c′. While a lengthof the catch slot 46′ can be depend, at least in part, on the dimensionsof the other features of the card, the size of the filament, and thetype of procedure in which the card and suture are being used, in oneexemplary embodiment a length of the catch slot 46′ is in the range ofabout 0.5 millimeters to about 3 millimeters, and in one embodiment itis about 1 millimeter.

FIG. 11 illustrates a third feature of the suture management card 10′designed to help prevent inadvertent off-loading of a suture. Thisfeature is a boot notch 48′ formed in the first sidewall 16′ of thesecond deflectable tang 29′. The notch 48′ can have a variety of shapes,but as shown it is substantially triangular in shape. The boot notch 48′is designed to prevent inadvertent offloading when filament limbs 54, 55are brought from the second surface 22′ (not shown) and around to thefirst surface 20′. More particularly, if no boot notch 48′ is present,as the filament limbs 54, 55 are brought around in this manner, they cansupply a force in an approximate direction C sufficient to deflect thesecond deflectable tang 29′ a distance that allows the filament limbs54, 55 to escape the third slot 24 c′. However, when the filament limbs54, 55 are caught by the boot notch 48′, the tang 29′ is not generallyable to deflect enough to cause inadvertent off-loading because thenotch 48′ can catch the filament limbs 54, 55 before they are allowed tocompletely bridge the gap and escape when the tang 29′ deflects.

FIG. 12 illustrates the second suture management card 10′ disposed inthe handle 90 of the inserter tool 80. The card 10′ can be inserted intothe handle 90 in a manner similar to the card 10, including, by way ofnon-limiting example, with an auditory feedback during a snap fit toprovide assurance that the card 10′ is properly situated in the handle90. As shown, the open-ended slot 26′ of the card 10′ can face out ofthe handle 90 such that when the card 10′ is removed from the handle 90,the filament limbs 54, 55 disposed therein are pushed out by the slot26′ and become readily available for use by the surgeon.

As shown, the handle 90 includes first and second suture-receiving slots94, 95. While the slots 94, 95 can have many different shapes andconfigurations, in the illustrated embodiment the first slot 94 has arelatively fixed width and depth, and is generally configured to receivethe filaments limbs 54, 55 as they initially pass off the card 10′,through the slot 42′ (not shown) formed in the second end 14′, andtoward the anchor. Additionally, the slot 94 can also receive thefilament limbs 54, 55 after they extend proximally toward the handle 90,from the anchor with which the limbs 54, 55 are coupled. In theillustrated embodiment, the limbs 54, 55 extending toward the anchor arenot initially encapsulated by a sleeve, but the limbs 54, 55 extendingback toward the handle 90 are encapsulated by a sleeve 58. Therelatively fixed width of the slot 94 can generally be wide enough sothat the filament limbs 54, 55 disposed therein loosely extendtherethrough but are not held in place by the slot 94. In one exemplaryembodiment, a width of the slot 94 is in the range of about 2millimeters to about 5 millimeters, and in one embodiment the width isabout 3 millimeters, while a depth is in the range of about 4millimeters to about 10 millimeters, and in one embodiment the depth isabout 6 millimeters. The length is generally the length from the handleslot 92 to the end of the handle 90, which in one exemplary embodimentis in the range of about 0.5 centimeters to about 3 centimeters, and inone embodiment is about 1.2 centimeters.

The second suture-receiving slot 95 is different than the first slot 94in that it includes a pinch point 99 that is configured to engage andhold the sleeve 58 in place when the card 10′ is disposed in the handle90 during anchor implantation, and help strip the sleeve out of the slot95 when the card 10′ is removed from the handle 90. The pinch point 99is defined by a portion of the slot 95 having a reduced depth and width.Thus, while a distal end 95 d of the second slot 95 can have a depth andwidth similar to that of the first slot 94, in one embodiment a depthcan become shallower on each side of the pinch point 99. The depth candecrease progressively so as not to have a sharp edge against which thesuture filament disposed therein frays or chafes. Likewise, a width ofthe slot 95, particularly at the pinch point 99, can become smaller sothe sleeve 58 can actually be grasped by the pinch point 99. As shown,the width associated with the pinch point 99 can become progressivelysmaller, although the decrease in depth of the second slot 95 does notnecessarily coincide with the decrease in a width of the slot 95. Thewidth of the pinch point 99 can be such that it holds the sleeve 58 inplace during anchor insertion, but allows the limbs sleeve 58 to bepulled out of the handle 90 at the same time the card 10′ is pulled out.In one exemplary embodiment, a smallest width of the pinch point 99 isin the range of about 0.25 millimeters to about 0.5 millimeters, and inone embodiment is about 0.3 millimeters, while a smallest depth of thepinch point 99 is in the range of about 2 millimeters to about 5millimeters, and in one embodiment is about 3 millimeters. In theillustrated embodiment, a length of the second slot 95 preceding thepinch point 99 is about the same as the length of the entire first slot,while the pinch point 99 adds a length to the slot in the range of about0.5 centimeters to about 2 centimeters, and in one exemplary embodimentit adds a length to slot that is about 0.8 centimeters.

The handle 90 can have any size and shape that is generally useful for asurgeon during a surgical procedure. In one exemplary embodiment, thehandle 90 is substantially cylindrical, having a diameter in the rangeof about 1.5 centimeters to about 4 centimeters, for instance about 2.5centimeters, and a length in the range of about 8 centimeters to about16 centimeters, for instance about 12 centimeters. The handle 80 can bemade out of materials typically used for medical device insertion tools,such as polymers or metals. In one exemplary embodiment, the handle 80is made of a thermoplastic such as acrylonitrile butadiene styrene(ABS).

The shaft 82 of the inserter tool 80 can extend distally from the handle90 and can be generally elongate. A distal end 82 d of the shaft 82 canbe configured to mate to an anchor 100 with which the suture filament 50will be coupled. In the illustrated embodiment of FIG. 13, a terminalportion of the shaft's distal end 82 d includes a reduced circumferencefor receiving the suture anchor 100. Optionally, a groove 84 can beformed in the distal end 82 d to help guide the filament 50 into a bore102 of the anchor 100 and also to protect the filament 50 fromunintended fraying or chafing. As shown, the groove 84 increases indepth as it extends distally, extending into the reduced circumferenceportion of the shaft 82 that couples with the anchor 100. The depth ofthe groove 84 can depend on the size of the filament 50 that will bedisposed therein, and a person skilled in the art is able to determine adesirable depth based on the other components of the system and the typeof surgical procedure being performed. The length of the shaft 82 canlikewise depend on the other components of the system and the type ofsurgical procedure being performed, but in one embodiment a length ofthe shaft 82 is in the range of about 18 centimeters to about 30centimeters, and in one embodiment is about 24 centimeters. Any numberof materials can be used to form the shaft 82, including biocompatiblematerials and metals. In some exemplary embodiments, the shaft 82 ismade of a stainless steel or titanium.

One skilled in the art will appreciate that a variety of suture anchortypes can be used in conjunction with the systems provided herein. Forexample, in some embodiments, such as those illustrated in FIGS. 14A and14B, the anchor 100 can be a Gryphon™ anchor that is commerciallyavailable from DePuy Mitek, LLC. The anchor 100 can include one or moremating features, such as threads, to allow the anchor to be fixedlydisposed in bone, a bore 102 formed in a proximal end and extendingsubstantially therethrough, and a distal engagement feature 104 disposedat a distal end for receiving a suture filament 50. As shown, the limbs54, 55, which are disposed in the sleeve 58, can extend distally downthe shaft 82 of the tool 80, into the groove 84, into and through thebore 102 of the anchor 100, around the filament engagement feature 104,back through the bore 102, back into the groove 84 and out of the anchor100, and finally proximally up the shaft 82 of the tool 80, toward thehandle 90. As discussed above, limbs 54, 55 extending from the card 10′can be encapsulated in the sleeve 58′ prior to entering the anchor 100at least to assist with suture filament management.

In one exemplary embodiment, illustrated in FIG. 15, the anchor 100, andthe suture filament limbs 54, 55 disposed in the sleeve 58 attachedthereto, are inserted into bone 108 and the filament limbs 54, 55 extendfrom the anchor 100 and through tissue 106 to be drawn to the bone 108as described in greater detail below.

After the anchor 100 is inserted to the surgical site, the suturemanagement card 10, 10′ can be removed from the handle 90 and theinserter tool 80 removed from the surgical site. The configuration ofthe handle 90, suture management card 10′, and suture filament 50 isillustrated in FIG. 16A. As shown, the card 10′ is disposed in thehandle 90, exposed filament limbs 54, 55 and portions of the limbs 54,55 encapsulated by the sleeve 58 are disposed in the firstsuture-receiving slot 94, and the sleeve 58 is disposed in secondsuture-receiving slot 95. More particularly, the limbs 54, 55 extend outof the card 10′ by passing through the slot 42′ formed in the secondsurface 22′ of the second end 14′, through the receiving slot 94, andtoward the anchor 100, with the sleeve 58 encapsulating the limbs 54, 55at some point between the handle 90 and the anchor 100. The sleeve 58 iscoupled to the anchor 100, and then extends back toward the handle 90.As shown, the sleeve 58 enters the receiving slot 94, passes through theslot 42′ and into the opening 26′ of the card 10′, and then extendsthrough an opening 95 o disposed between the receiving slot 94 and thesecond suture-receiving slot 95.

As shown in FIGS. 16B and 16C, the surgeon can lift the card 10′ out ofthe handle 90, thereby pulling the sleeve 58 disposed in the handle 90,out of the handle 90. The open-ended slot 26′ picks up the distalportion of the sleeve 58 and applies enough tension to the portion ofthe sleeve 58 disposed in the pinch point 99 to disengage the sleeve 58from the pinch point 99. The design of pinch point 99 is such that ithelps strip the sleeve 58 out of the slot 95 as the card 10′ is removedfrom the handle 90. Because the slot 26′ has an open end, the distalportion of the sleeve 58 can fall away from the card 10′. As shown inFIG. 16D, with the card 10′ fully removed from the handle 90, the freelimbs 54, 55 disposed in the sleeve 58 fall out of the open-ended slot26′ and the free limbs 54, 55 extending from the third slot 24 c′ arealso readily identifiable by the surgeon. The repair can continue withthe sleeve remaining disposed around the free limbs 54, 55, oralternatively it can be removed and the four free limbs 54, 55 can beused to complete the repair.

FIGS. 17A-17I illustrate the next steps to perform after the anchor hasbeen implanted and the suture management card has been removed from theinserter tool. While these figures refer to the first suture managementcard 10 to demonstrate the steps, these steps are equally applicable tothe second suture management card 10′.

As shown in FIG. 17A, the distal portion of the filament limbs 54, 55,which are disposed in the sleeve 58, can be passed through the openingdefined by the collapsible loop 52. The sleeve 58 is then folded overthe loop 52 so that it can be used to apply a force to the loop 52 in anapproximate direction D, as shown in FIG. 17B. Once the amount of forceapplied by the sleeve 58 exceeds the ejection threshold tension, theloop 52 can stretch and eventually eject from the card 10, asillustrated in FIG. 17C, while the limbs 54, 55 extending from the knot56 can remain in the slots 24, resisting the tension force. As shown inFIG. 17D, the application of force to the distal portion of the sleeve58 in the approximate direction D in an amount that exceeds thecollapsing threshold tension after the loop is ejected from the card 10can draw the sliding knot 56 toward the distal portions of the sleeve58, i.e., cinching the loop. Again the limbs 54, 55 extending from theknot 56 can remain substantially in the same position with respect tothe slots 24. It is the resistance created by the limbs 54, 55 disposedin the slots 24 that the knot 26 draws towards the distal portion of thesleeve 58. Eventually, the force is such that the knot 56 slides all theway to the location where the force is being applied by the sleeve 58,as shown in FIG. 17E.

Once the knot 56 is adjacent to the sleeve 58 and the loop 52 is thusfully collapsed, tension can be applied by the sleeve 58 in a differentdirection to help offload the remaining portions of the filament 50 fromthe card 10. As shown in FIG. 17F, a force can be applied in anapproximate direction E to dislodge the filament limbs 54, 55 from thefirst slot 24 a. Likewise, as shown in FIG. 17G, a force can be appliedin an approximate direction F to dislodge the filament limbs 54, 55 fromthe second slot 24 b. Because in the illustrated embodiment the raisedsection 44 is ramped, and the loop 52 is no longer mounted on the prongs30, 32, the raised section 44 does not make offloading difficult like itdid before the loop 52 was ejected off the card 10. Further, as shown inFIG. 17H, forces can be applied to dislodge the filament limbs 54, 55from the third slot 24 c. Because the third slot 24 c includes theV-shaped second portion 24 c ₂, forces will typically need to be appliedin more than one direction to work the suture limbs 54, 55 up and overthe vertex of the V-shaped portion and then out of the remaining portionof the third slot 24 c. Once the suture filament 50 is fully removedfrom the suture management card 10, as shown in FIG. 17I, the card 10can be discarded or reloaded with another suture for use, while thesuture filament 50 can be used to complete the soft tissue repair.

As shown in FIG. 18A, with the suture filament 50 disassociated from thesuture management card, the anchor 100 and filament 50 combination canbe used to complete the soft tissue repair. A circled loop 57 is formedat the location of where the sliding knot 56 is cinched against thedistal portion of the sleeve 58. As shown, the cinched loop 57 defines anew loop 59 that extends distally from one side of the cinched loop 57,around the distal engagement feature 104 of the anchor 100. Extendingproximally from the other side of the cinched loop 57 are the terminalends of the filament limbs 54, 55, which as shown can still be disposedin the sleeve 58.

As shown in FIG. 18B, tension can be applied to the sleeve 58 by pullingin an approximate direction G, thereby causing the cinched loop 57 toslide distally toward the tendon 106 in a zip-line like manner until thecinched loop 57 is adjacent to the tendon 106. As shown in FIG. 18C, thesleeve 58 can be removed, thereby exposing the first and second limbs54, 55. The limbs 54, 55 can then be cinched or otherwise tied togetherto assist in securing a location of the cinched loop 57, and thus thetendon 106, with respect to the bone 108, as illustrated in FIG. 18D. Inthe illustrated embodiment, a half-hitch 109 is formed by the surgeonusing the first and second limbs 54, 55. A second half-hitch can beformed to lock the location of the first half-hitch 109, and thus theloop 59 and tendon 106.

Although in the illustrated embodiment the construct is passed throughtwo portions of tendon 106, alternatively the construct can be passedthrough only one portion of tendon or tissue while the second portion ofthe construct can be free of the tendon or tissue. Such an embodimentcan be used, for example, during a labral repair. Either of the two endscan be the end that is not passed through the tendon or tissue, althoughin some exemplary embodiments the end not with the knot and extendingfrom the card is not the end passed through the tendon or tissue.Further, in some embodiments, rather than passing through tissue, arepair construct can be coupled to tissue using other techniques, suchas, for example, by wrapping the construct around the tissue.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Further,although the constructs and methods provided for herein are generallydirected to surgical techniques, at least some of the constructs andmethods can be used in applications outside of the surgical field. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A surgical implant system, comprising: an implantinserter device having a handle and a shaft extending distally from thehandle, the handle having a slot formed therein and configured toreceive a suture management card, and the shaft having a distal endconfigured to engage a surgical implant; a suture having a collapsibleloop defined by a sliding knot and first and second free limbs extendingon a side of the sliding knot opposite the collapsible loop; and asuture management card configured to hold open the collapsible loopuntil a force applied to the loop is greater than a threshold tension,and configured to be selectively inserted in and removed from the slotof the handle, wherein the suture management card is configured suchthat when it is removed from the slot of the handle, the first andsecond free limbs of the suture are accessible and capable of beingdisposed through an opening of the collapsible loop held open by thesuture management card to apply a force thereto.
 2. The system of claim1, wherein the suture management card further comprises: a first endconfigured to hold open the collapsible loop until a force applied tothe loop is greater than the threshold tension; a second end having anopening formed therein and configured to receive a distal portion of thefirst and second free limbs; and first and second sidewalls extendingbetween the first and second ends.
 3. The system of claim 2, wherein theopening formed in the second end extends from the second sidewall andtowards the first sidewall, terminating prior to the first sidewall. 4.The system of claim 1, wherein the handle comprises first and secondsuture-receiving slots formed in a distal end thereof, the first andsecond suture-receiving slots being configured to receive the first andsecond free limbs.
 5. The system of claim 4, wherein the secondsuture-receiving slot comprises a pinch point formed in a portionthereof and configured to engage the first and second free limbs fromopposed sides when the suture management card is disposed in the handle,the pinch point being configured to release the first and second freelimbs when the suture management card is removed from the slot formed inthe handle.
 6. The system of claim 1, further comprising a surgicalimplant having a proximal end and a distal end, the proximal end havinga bore formed therein and being coupled to the distal end of the shaft,and the distal end having a filament engagement feature configured toreceive the first and second free limbs, wherein the first and secondfree limbs are disposed through the bore of the proximal end of thesurgical implant, around the filament engagement feature of the surgicalimplant, and back through the bore of the proximal end of the surgicalimplant.
 7. A surgical method, comprising: implanting at a surgical sitea suture anchor having a suture coupled thereto using an insertion tool,the insertion tool having a suture management card removably disposed ina portion thereof, and a collapsible loop of the suture that is heldopen by the suture management card, the collapsible loop being definedby a sliding knot formed in the suture; removing the suture managementcard from the handle; grasping a free limb of the suture that isdisposed on a side of the sliding knot opposite the collapsible loop;positioning a distal end of the free limb in an opening of thecollapsible loop maintained by the suture management card; applying aforce to the free limb sufficient to disengage the collapsible loop fromthe suture management card; decoupling the free limb from the suturemanagement card; and applying tension to the free limb to collapse thesliding knot toward the surgical site to secure tissue to bone.
 8. Themethod of claim 7, further comprising inserting the suture managementcard into the insertion tool to secure a distal portion of the free limbin the insertion tool during implantation of the suture anchor.
 9. Themethod of claim 7, wherein decoupling the free limb from the suturemanagement card further comprises applying tension to the free limb in adirection approximately perpendicular to a sidewall of the suturemanagement card to free the free limb from one or more resistancefeatures of the suture management card.